Moleculin Biotech, Inc. (NASDAQ:MBRX) Q4 2022 Earnings Conference Call March 23, 2023 8:30 AM ET Company Participants Jenene Thomas - Investor Relations Walter Klemp - Chairman and Chief Executive Officer John Paul Waymack - Senior Chief Medical Officer Jonathan Foster - Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Jeff Jones - Oppenheimer Operator Hello and welcome to the Moleculin Biotech Fiscal Year 2022 Quarterly Update Conference Call and ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF For the transition period from to Commission File Number: 001-37758 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of (Primary Stan ...

Moleculin Biotech, Inc. (NASDAQ:MBRX) Q3 2022 Earnings Conference Call November 10, 2022 5:00 PM ET Company Participants Walter Klemp – Chairman and Chief Executive Officer Jonathan Foster – Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff – ROTH Capital Operator Hello, and welcome to the Moleculin Biotech Inaugural Quarterly Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode. [Operator Instructions] ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MOLECULIN BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MOLECULIN BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or O ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 47-4671997 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification Number) 5300 Memorial Drive, Suite 950 Houston, TX 77007 (Address of principal executive offices) (Z ...

Better Treatments, More Tomorrows INVESTOR PRESENTATION / FEBRUARY 15, 2022 MOLECULIN.COM / NASDAQ: MBRX Disclaimer All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are inten ...

Drug Development and Clinical Trials - The company has six drug candidates, three of which have shown human activity in clinical trials[19] - The company expects to have up to ten clinical trials active or concluded by the end of 2022[25] - The company is seeking collaborative partners for a Phase 2 clinical trial of WP1220 in CTCL[33] - The ongoing geopolitical uncertainties may impact the company's clinical trials and drug supply[36] - The company is focused on developing treatments for highly resistant cancers and viruses, including AML, GBM, STS lung metastases, and COVID-19 variants[38] - The company is exploring additional strategic collaborations and grant-funded opportunities to support its drug candidates[41] - The company is independently funding its WP1122 antiviral program, which has received FDA clearance for a Phase 1 clinical trial[43] - The company plans to initiate a Phase 1 trial of WP1122 for COVID-19 in the UK in the first half of 2022[22] - The company plans to initiate a European Phase 1/2 AML trial with AnnAraC in the first half of 2022, following the successful completion of a single-agent trial[81] - The company is collaborating with WPD and physicians in Poland for a Phase 1b/2 clinical trial of Annamycin, funded by a $1.5 million USD grant[105] Annamycin and Its Efficacy - Annamycin has demonstrated a 60% objective response rate (ORR) in the last cohort of a Phase 1 trial for relapsed and refractory acute myeloid leukemia (AML) in Poland[27] - Annamycin has shown no cardiotoxicity in subjects treated to date in clinical trials[20] - A Phase 1 clinical trial of Annamycin for relapsed and refractory AML successfully concluded in 2020, meeting the primary endpoint of safe administration up to the lifetime maximum allowable dose[54] - The company established a recommended Phase 2 dose (RP2D) of 240 mg/m2 for Annamycin in its ongoing Phase 1/2 trial in Europe, demonstrating an overall response rate (ORR) of 60% in the final cohort[55] - Preclinical studies suggest that the combination of Annamycin with Cytarabine (AnnAraC) may be 68% more effective for R/R AML patients compared to Annamycin alone[55] - Annamycin has shown no cardiotoxicity in three Phase 1 clinical trials, with less than 10% incidence of alopecia compared to 65%-92% for doxorubicin[65] - Annamycin demonstrated a 100% survival rate in a preclinical study for metastatic osteosarcoma, compared to only 10% for untreated animals[78] - Annamycin's uptake in the lungs is over 30-fold higher than that of doxorubicin, suggesting potential effectiveness against STS lung metastases[77] - Annamycin may circumvent multidrug resistance mechanisms, allowing for higher drug uptake in diseased cells[69] - Annamycin clinical trials demonstrated a 60% overall response rate (ORR) with two partial responses (PRs) and one complete response (CRi) at a dose of 240 mg/m2[87] WP1066 and Related Trials - The WP1066 Portfolio includes lead drug candidates WP1066 and WP1220, targeting oncogenic transcription factors, with FDA granting Orphan Drug Designation (ODD) for WP1066 for glioblastoma[110] - WP1066 has shown significant anti-tumor activity in various solid tumors, including head and neck, pancreatic, stomach, and renal cancers, as well as glioblastoma[122] - A physician-sponsored Phase 1 trial of WP1066 for recurrent malignant glioma has generated pharmacokinetic data demonstrating sufficient bioavailability via oral administration[125] - The combination of WP1066 and WBRT resulted in enhanced median survival time in the GL261 glioma model, with a p-value of <0.0001 compared to monotherapy[128] - The Emory trial for pediatric brain tumors has treated three subjects, with one subject showing clinical improvement and a radiologic reduction of tumor size[130] Market Opportunities and Competition - The American Cancer Society estimates 1.9 million new cancer cases and 609,360 cancer deaths in the US for 2022, highlighting the significant market opportunity for oncology drugs[151] - The market for acute myeloid leukemia (AML) therapies is projected to grow from $153 million in 2016 to $1.6 billion by 2025, with the US holding the largest share[153] - The market for soft tissue sarcoma (STS) with lung metastases is expected to increase from $177 million in 2017 to $198 million by 2030[159] - The incidence of cutaneous T-cell lymphoma (CTCL) is estimated to grow from 16,000 in 2020 to 18,000 by 2026, with a significant unmet need for effective treatments[168] - There are currently 551 ongoing clinical trials for pancreatic cancer, indicating intense competition in this therapeutic area[199] Regulatory and Development Challenges - Regulatory approvals for pharmaceutical products are extensive and can be costly and time-consuming, impacting development timelines[204] - The FDA aims to complete the NDA review within 10 months of the 60-day filing date, which translates to within 12 months of submission, although this deadline may be extended under certain circumstances[215] - The FDA may grant Accelerated Approval based on data demonstrating an effect on a surrogate endpoint that is likely to predict clinical benefit[218] - The FDA may require a risk evaluation and mitigation strategy (REMS) to ensure the safe use of the product[217] - The submission of an NDA is subject to a substantial fee under the Prescription Drug User Fee Act (PDUFA), which may be waived under certain circumstances[214]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MOLECULIN BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (Primary ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37758 MOLECULIN BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State or Oth ...